Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04764994
Eligibility Criteria:
Inclusion Criteria:
Forty Saudi stroke male participants will be included in this study.
* The participating participants will have a confirmed diagnosis of stroke confirmed by magnetic resonance images (MRIs) obtained from medical records or personal physicians.
* They should be medically stable and will have neither serious nor recurring medical complications according to the medical report signed by their physician.
* The age of participants will be between 50 to 60 years.
* Participants of both genders will be recruited
* The participants will be selected to be in spastic phase, 6-24 months following a first stroke.
* The degree of spasticity in upper extremity according to Modified Ashworth Scale will ranged between grades 1,1+\&2.
* The included participants should be cognitively competent and able to understand and follow instructions.
* The participants will associated with neither fixed stiffness in shoulder, elbow, wrist and fingers joints nor major rotational mal-alignments in the upper limbs.
* The patient should have the ability to extend the wrist at least 20° and fingers 10° from full flexion. This range will allow participants to engage easily in performing a designed program.
* Also they should have no serious problems affecting balance performance other than spasticity due to stroke.
* During the study, participants will not receive any treatment to improve involved upper limb functions other than the study intervention.
Exclusion Criteria:
Participants will be excluded from study if they have:
* Cognitive decline (Mini-Mental State Examination \< 23 points). Due to the requirements of the ARMEO system.
* Shoulder pain on a visual analogue scale of \> 6/10.
* Spasticity score ≥ 2 according to the Modified Ashworth Scale
* Conditions affecting their participations in this study (e.g. cardiac, respiratory, seizures or arthritic problems)
* Visual problems that may prevent them from performing the intervention
* Botulinum toxin in the upper extremity musculature six months before baseline assessment or who wished to receive it within the period of study,
* Muscle-tone control medications before baseline assessment or who wished to receive it within the period of study.
* A cardiac pacemaker as the electromagnetic motion tracker used within the virtual reality system might interfere with such devices.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
60 Years
Study:
NCT04764994
Study Brief:
Protocol Section:
NCT04764994